Phase 3
Completed N=221
18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment
Source: ClinicalTrials.gov NCT02680041 ↗Enrolled (actual)
221
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease. — 126; 87; 88; 34 Participants
◆ Published Evidence
Established
31citations · ~4 / year
Fluorine-18-Labeled Fluciclovine PET/CT in Clinical Practice: Factors Affecting the Rate of Detection of Recurrent Prostate Cancer.
Summary
This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent prostate cancer after curative-intent primary therapy and negative or equivocal findings on standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine PET/CT. Site clinicians will manage study subjects per standard practices and will document any change in treatment based on review of 18F-fluciclovine PET/CT findings. All participants will be followed for up to 6 months, with clinical data collected for this study. An interdisciplinary panel will provide expert guidance to local readers on request. The final reporting of the PET/CT scan will be a single report by the local reader following any such discussion.
Linked Publications (2)
-
Fluorine-18-Labeled Fluciclovine PET/CT in Clinical Practice: Factors Affecting the Rate of Detection of Recurrent Prostate Cancer.
-
Impact of <sup>18</sup>F-fluciclovine PET/CT on plans for androgen deprivation therapy in patients with biochemical recurrence of prostate cancer: data analysis from two prospective clinical trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease. |
126; 87; 88; 34; 38; 53 | — |
| SECONDARY The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment |
80; 131; 47; 74; 33; 57 | — |
| SECONDARY The Rate of Detection of Any Disease Site by 18F-fluciclovine PET/CT in the Study Population |
122 | — |
| SECONDARY The Rate of Detection of Disease in 1) Prostate and Prostate Bed and 2) Extra-prostatic Regions With 18F-fluciclovine PET/CT in the Study Population |
64; 80 | — |
| SECONDARY The Positive Predictive Value (PPV) of 18F-fluciclovine PET/CT for Regional Disease Compared to Biopsy in Those Patients Who Undergo Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy |
100 | — |
| SECONDARY The PPV of 18F-fluciclovine PET/CT for Distant Disease Compared to Biopsy in Those Patients Who Undergo a Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy |
100 | — |
Eligibility Criteria
Inclusion Criteria
- History of histologically confirmed adenocarcinoma of the prostate post curative-intent local treatment (radical prostatectomy, local radiotherapy, brachytherapy).
- Suspicion of recurrent prostate carcinoma after previous presumed definitive therapy for organ confined disease defined as :
- Post prostatectomy: Detectable or rising PSA level that is >0.2 ng/mL with a second confirmatory level of >0.2 ng/mL
- Post non-prostatectomy: PSA rise ≥ 2ng/mL over nadir
- Negative or equivocal findings on standard-of-care imaging for restaging of disease in the previous 60 days consisting of: Whole-body 99mTc bone scintigraphy or NaF PET-CT; and either CT or MRI of the pelvis (or the abdomen and pelvis).
- Being considered for salvage therapy
- Any non-surgical local treatment such as previous cryotherapy, external beam radiation, or HiFU (Ultrasound) must have occurred at least 1 year in the past.
- Previous brachytherapy treatment will have occurred at least 2 years in the past
- Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria
- Ongoing treatment with any systemic therapy intended for the treatment of prostate cancer (e.g., antiandrogen or LHRH agonist or antagonist)
- Androgen deprivation therapy (ADT) in the past 3 months
- History of bilateral orchidectomy
- Inability to tolerate 18F-fluciclovine PET/CT
Data sourced from ClinicalTrials.gov (NCT02680041) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.